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New treatment option for Type2diabetes
Official title Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT07416799
What this study is testing
- What it's testing
- This is a single-arm feasibility study employing a pre-post design with a 12-week intervention period. The study utilizes a telehealth-assisted home-based resistance exercise program, with a structured progression from supervised to unsupervised sessions over 12 weeks.
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- Age: 55-80 years
- Diabetes: Diagnosed T2DM with ≥5 years duration
- Cognitive Status: Mild cognitive impairment as defined by Petersen criteria and confirmed by Montreal Cognitive Assessment (MoCA) scores of 18-25
- Medication Stability: Stable medication regimen for at least 3 months
- Physical Capability: Physically capable of participating in moderate-intensity exercise (physician clearance required)
You likely can't join if
- Diagnosis of movement disorders such as multiple sclerosis, parkinson's disease
- Diagnosis of Alzheimer's disease,
- Current diagnosis of severe depression, major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could...
- Significant cerebral vascular disease
- Concomitant medications with significant cholinergic or anticholinergic effects or adverse effects on cognition, including antipsychotics, tricyclic...
- Visual/hearing impairment that would significantly impact the ability to participate in psychometric testing.
See the full eligibility criteria
- Age: 55-80 years
- Diabetes: Diagnosed T2DM with ≥5 years duration
- Cognitive Status: Mild cognitive impairment as defined by Petersen criteria and confirmed by Montreal Cognitive Assessment (MoCA) scores of 18-25
- Medication Stability: Stable medication regimen for at least 3 months
- Physical Capability: Physically capable of participating in moderate-intensity exercise (physician clearance required)
- Support System: Having a caregiver or support person willing to assist with technology use if needed
- Diagnosis of movement disorders such as multiple sclerosis, parkinson's disease
- Diagnosis of Alzheimer's disease,
- Current diagnosis of severe depression, major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or cooperate fully with the protocol.
- Significant cerebral vascular disease
- Concomitant medications with significant cholinergic or anticholinergic effects or adverse effects on cognition, including antipsychotics, tricyclic antidepressants, anticonvulsants, sedative/hypnotics, anxiolytics...
- Visual/hearing impairment that would significantly impact the ability to participate in psychometric testing.
- Significant medical illness or organ failure, including hepatic or renal failure, unstable cardiac disease,
- Untreated B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable).
- Uncontrolled hypertension: over 160 mmHg systolic or 100 mmHg diastolic (stable treatment is allowable).
- Stage 5 renal impairment (GFR less than 15 or dialysis).
- Participation in another clinical trial.
- Prisoners.
- Exercise Contraindications: Any condition that would make moderate-intensity exercise unsafe such as a history of severe aortic stenosis, poorly controlled hypertension, angina, or syncope.
- Lack of Support: No available caregiver or support person for technology assistance
The study team makes the final eligibility decision.
Where it's taking place
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.